It’s been awhile since we visited the world of “illegal” equine supplements, which includes a host of common products, from glucosamine and chondroitin to MSM to all herbals. These ingredients fall outside existing FDA regulations — that everything an animal consumes must be classified either as a feed or a drug — and are considered illegal.
By definition, feeds include only the basics of protein, fat, carbohydrate and essential vitamins and minerals, plus such things as preservatives, binders and probiotics. Technically, everything else an animal consumes, including nutraceuticals, is considered a “drug,” which means it must conform to the same quality and efficacy standards as prescription drugs.
Human supplements are exempt from this drug definition by virtue of the DSHEA, which acknowledges that a sound diet and dietary supplements can benefit health. It also provided a broad definition of “dietary supplement” that includes more than basic protein, vitamins and minerals. In addition, the DSHEA considers dietary supplements to be safe unless an ingredient presents “a significant or unreasonable risk of illness or injury” when used as directed, such as occurred with ephrada. However, the DSHEA didn’t specifically include animals, and this resulted in a flurry of regulatory activity directed against unapproved animal-supplement ingredients.
Although a few states have banned the sale of any supplement that doesn’t fit existing guidelines, most have listened to public outcry and appear to have the issue on hold until the regulatory issues can be worked out. Manufacturers are leading the way, and the most promising hope is through the NASC, the National Animal Supplement Council.
Bill Bookout, president of the NASC, said the group started with a plan called Compliance Plus, which was basically an attempt to get AAFCO and the FDA to call off the dogs by putting forth a proposal to establish adverse-event reporting and product-labeling guidelines, get formal research underway on these ingredients and to establish manufacturing standards. The NASC also submitted formal petitions to the FDA to get approval of glucosamine and MSM as feed/supplement ingredients, although they were denied.
The goodwill these actions demonstrated, as well as an impressive outpouring of public sentiment when Iowa attempted to ban illegal supplement sales, essentially led to a cease fire in the supplement war. However, the door remains wide open for them to be pulled off the market at any time, which also creates complicated liability and insurance issues for manufacturers.
The NASC’s membership includes 65% of the manufacturers involved in animal supplements. Member companies receive guidance from the NASC for labeling, manufacturing practices and quality control measures to ensure a safe, consistent product. The NASC’s adverse-event monitoring system requires companies to record the number of doses sold of each product/ingredient, as well as any adverse reports from consumer, and gives the FDA direct access to that data. The NASC hopes to introduce legislation by early 2005 that would grant animal supplements the same legal status as similar human ones.
The NASC also instituted a “seal of approval” program. Companies that successfully pass a facility inspection and audit of their practices and participate in the adverse-event reporting process may display an NASC seal on their products. The seal carries no legal or regulatory power but does tell you that the manufacturer is actively involved in the fight to make supplements legal and raise the bar on supplement quality and safety.
It’s also important to realize that, although the NASC membership ranks include both small and large companies, some manufacturers have decided not to go for the NASC seal, since conforming to the NASC standards really doesn’t do a thing to enhance the chances their product won’t be removed from the market.
The NASC hopes their standards will be used in upcoming legislation. If that happens, NASC members will have a jump on things, but companies that aren’t current members, or aren’t involved in the NASC seal program, can still get on board by doing whatever might be necessary to bring their operations into line with what will then be legally binding standards.
For more details on the NASC, go to www.nasc.cc.
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